Dual lumen iv administration set

ABSTRACT

A dual lumen IV administration set includes a first lumen having an inner diameter of a first value. A second lumen is paired with the first lumen, and the second lumen has an inner diameter of a second value that is greater than the first value. A flow merger merges flow output from a distal end of the first lumen and flow output from a distal end of the second lumen to form a single flow output in an exit lumen. An injection port intersects the first lumen, thereby providing injection access to flow therethrough, prior to merging with the flow output of the second lumen.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority to U.S. Non-Provisional PatentApplication No. 16/869,009, filed on May 7, 2020, which claims priorityto U.S. Provisional Patent Application No. 62/845,769, filed on May 9,2019, entitled “IV Administration Set,” and to U.S. Provisional PatentApplication No. 62/849,742, filed on May 17, 2019, entitled “IVAdministration Set,” and to U.S. Provisional Patent Application No.62/858,133, filed on Jun. 6, 2019, entitled “IV Administration Set,” andto U.S. Provisional Patent Application No. 62/971,435, filed on Feb. 7,2020, entitled “IV Administration Set,” and incorporates each in itsentirety by reference.

BACKGROUND

In the modern world, during medical procedures, particularly thoseinvolving anesthesia, it is common that saline and other health oranesthesiology-related drugs are administered to those undergoingsurgery via an intravenous (IV) drip line. The techniques and variancesof administration of the fluid and drugs (hereinafter referred to as “IVadministration”) are complex due to the many physical differences amongindividuals. Yet, the procedural steps taken to accommodate thedifferences tend to be fairly routine across various different types ofprocedures. That is, once the administrator knows what is needed for theindividual, it is essentially a matter of monitoring the patient andadministering the correct amounts or doses of fluid/drugs at the righttime, using the proper procedural steps according to the situation.

However, over the many years since IV administration was conceived andimplemented, the equipment available for such procedural IVadministration has changed little. Of course, advancements have beenmade in material technology, anti-bacterial capabilities, and somestructural enhancements of the apparatus used. Further, as theadministrators' knowledge of how the body functions has increased,variances in the process of administration has improved as well.Nevertheless, even the most skilled administrators still make errorsunintentionally, which errors might be minimized if the equipment wasimproved.

BRIEF DESCRIPTION OF THE DRAWINGS

The Detailed Description is set forth with reference to the accompanyingfigures. In the figures, the left-most digit(s) of a reference numberidentifies the figure in which the reference number first appears. Theuse of the same reference numbers in different figures indicates similaror identical items. Furthermore, the drawings may be considered asproviding an approximate depiction of the relative sizes of theindividual components within individual figures. However, the drawingsare not to scale, and the relative sizes of the individual components,both within individual figures and between the different figures, mayvary from what is depicted. In particular, some of the figures maydepict components as a certain size or shape, while other figures maydepict the same components on a larger scale or differently shaped forthe sake of clarity.

FIG. 1 illustrates a dual lumen procedural IV administration setaccording to an embodiment of this disclosure.

FIG. 2 illustrates another dual lumen procedural IV administration setaccording to an embodiment of this disclosure.

FIG. 3 illustrates an example flush pump according to an embodiment ofthis disclosure.

FIG. 4A illustrates a side view of a lumen roller clamp according to anembodiment of this disclosure.

FIG. 4B illustrates a top view of the lumen roller clamp in FIG. 4Aaccording to an embodiment of this disclosure.

FIG. 4C illustrates a bottom view of the lumen roller clamp in FIG. 4Aaccording to an embodiment of this disclosure.

FIG. 5A illustrates a fluid input end portion of the procedural IVadministration set of FIG. 2 according to an embodiment of thisdisclosure.

FIG. 5B illustrates an IV end portion of the procedural IVadministration set of FIG. 2 according to an embodiment of thisdisclosure

FIG. 6A illustrates a micro lumen injection port according to anembodiment of this disclosure.

FIG. 6B illustrates a macro lumen injection port according to anembodiment of this disclosure.

FIG. 7A illustrates a injection port cleaning device according to anembodiment of this disclosure.

FIG. 7B illustrates an alternative injection port cleaning deviceaccording to an embodiment of this disclosure.

DETAILED DESCRIPTION Overview

This disclosure is directed to various embodiments of an IVadministration set (“IV admin set,” “IV set,” or “set”). Depending onthe environment or user, embodiments of an IV administration setaccording to this disclosure may be referred to in different situationsas a procedural IV admin set, a run/stop IV admin set, a dual lumen IVadmin set, or a flush IV admin set—each of which may be interchangeablyused herein with respect to the IV administration set). Morespecifically, the subject matter herein is directed to a dual lumen IVset. An advantage of the embodiments of a dual lumen IV set describedherein is that an administrator, who is an individual authorized toadminister fluid and/or drugs via the dual lumen IV set, is able toadminister a medication separately from the main fluid delivery lumenduring a procedure. As such, the dual lumen IV set provides bothpatients and administrators greater efficiency, accuracy, speed, andprecision in fluid and drug delivery without interference with or fromthe main fluid delivery lumen. Such benefits may allow IV administrationto be more acutely tailored according to specific and instantaneous orunexpected needs of a patient's body. Other advantages provided by thedual lumen IV set may or may not be listed herein but may be recognizedby professional administrators upon use of an embodiment of a dual lumenIV set.

Illustrative Embodiments of a Dual Lumen IV Administration Set

FIG. 1 depicts an embodiment of a dual lumen IV admin set 100. Startingwith respect to a distal end or the “fluid input” end of the dual lumenIV set 100 may include: a spike 102 and a drip chamber 104 forattachment to a fluid bag (not shown) to administer saline or othersaline-like fluid according to the needs of the patient. The spike 102may be the same or similar to known medical-industry spikes used to drawfluid from a saline bag. Additionally, the drip chamber 104 may be thesame or similar to known drip chambers used in existing IV sets.

In an embodiment, a single input flow line 106 may extend from dripchamber 104. Due to distinctions of features (i.e., two lumens ofdifferent sizes) of the instant disclosure compared to a conventionalsingle lumen IV admin set, the single input flow line 106 may bereferred to as a macro-sized IV tube, which size may be comparable tothe single lumen tubing of the conventional single lumen IV admin set.Moreover, in an embodiment not shown, but contemplated by the inventors,the input flow may be split into two separate input lines to directlymeet the dual lumens of the dual lumen IV admin set 100. However, suchan input flow arrangement may be more cumbersome to use. Accordingly, asdescribed above and depicted, a single input flow line 106 may beimplemented more conveniently.

Continuing with the description of the additional features in FIG. 1 ,the single input flow line 106 is connected to the drip chamber 104 on aproximal end and may be connected to a check valve 108 on the distalend. Check valve 108 may be included in the dual lumen IV admin set 100to ensure fluid flows in only one direction, thereby preventing backflow. In general, the check valve 108 may be the same or similar toexisting check valves.

A flow splitter 110 is incorporated to facilitate directing fluid fromthe single input flow line 106 into both a first lumen 112 and a secondlumen 114 of the dual lumen IV admin set 100. The first lumen 112 mayalso be referred to herein as a “micro lumen” to describe the relativesize of the first lumen 112 with respect to the second lumen 114, or a“macro lumen.” That is, as an inner diameter of first lumen 112 issmaller than an inner diameter of second lumen 114, first lumen 112 hasa flow volume capacity that is less than the flow volume capacity ofsecond lumen 114. Thus, it is not intended to mean that the lumen inneror outer diameter are necessarily of “micro” dimensions, though such isa possibility. Note, as depicted in FIG. 1 , in an embodiment, the checkvalve 108 may be connected directly in line to the single input flowline 106. However, in an alternative embodiment as depicted in FIG. 2 ,the check valve (identified as 208) is positioned along the macro lumenafter the flow is split.

In an embodiment, first lumen 112 and second lumen 114 may be joined viaa thin webbing 113. Webbing 113 may be split as needed to separate firstlumen 112 from second lumen 114. However, other embodiments, such as anembodiment shown in FIG. 2 , may not include a webbing between firstlumen 112 and second lumen 114, such that the two lumens (112, 114) maybe manufactured as a unified body, which may be manually separated asneeded, or may be joined after formation via various techniques to bondthe lumens together. In an embodiment that includes webbing, othercomponents of the dual lumen IV administration set may be altered fromwhat is shown hereinafter to accommodate the webbing.

Dual lumen IV admin set 100 further includes one or more macro injectionports 116 intersecting the second lumen 114. Macro injection ports116—the structure of which is described in more detail below—are pointsof administrator access into the second lumen 114 with first lumen 112fluid flowthrough. The one or more macro injection ports 116intersecting the second lumen 114 may be used to injectfluids/medications into the second lumen 114 according to currentpractices. The injection ports may include luer lock adapters or othersuitable injection port adapter. Likewise, dual lumen IV admin set 100further includes at least one micro injection port 118 intersecting thefirst lumen 112. Micro injection ports 118 are points of administratoraccess into the first lumen 112 with second lumen 114 fluid flowthrough,and the structure of the micro injection port 118 is also described inmore detail below. Further, the at least one micro injection port 118intersecting the first lumen 112 may be used to inject medication andfluids that are better suited for minimal dilution and/or more directed,faster injection. Accordingly, the at least one micro injection port 118may be disposed nearer to the fluid output end of the dual lumen IVadmin set 100 than to the fluid input end thereof

In an embodiment, dual lumen IV admin set 100 may include a dual lumenclamping device 120. Dual lumen clamping device 120 may be configured tolockably secure and clamp both first lumen 112 and second lumen 114independently, to regulate the volume of flow therethrough. For example,a first roller 122 a may be positioned to roll in a grooved track, froma first end within dual lumen clamping device 120 to a second endthereof, and on a side securing first lumen 112, such that upon rollingfirst roller 122 a, first lumen 112 is compressed between first roller122 a and an inner wall dividing first lumen 112 from second lumen 114.Likewise, a second roller 122 b may be positioned to roll in a groovedtrack, from the first end within dual lumen clamping device 120 to thesecond end thereof, and on a side securing second lumen 114, such thatupon rolling second roller 122 b, second lumen 114 is compressed betweensecond roller 122 b and the inner wall.

Moreover, in an embodiment, first roller 122 a may function as amechanical timed locking clamp mechanism and second roller 122 b mayfunction as a lockable roller lock mechanism. That is, first roller 122a may include a track structure to act as a timed release, such that theclamping action on the lumen is maintained for a limited time before theclamp is self-released. Nevertheless, as described herein below, otherclamps may be used in other embodiments, in which only one of the lumensis compressed or compressable to regulate flow of fluid therethrough,and/or where no timed locking clamp mechanism is included.

Prior to terminating in a single lumen flow to provide fluid to apatient via a single entry point, a flow merger 124 is incorporated indual lumen IV admin set 100 to merge the flow of first lumen 112 andsecond lumen 114 back into a single exit lumen 126.

In an embodiment, dual lumen IV admin set 100 may incorporate a junctionelement 128, used to join exit lumen 126 with the extension tubing (notshown) that remains with the needle inserted in a patient. For example,junction element 128 may be a luer lock component, such as a male luerlock, though other suitable means of joining are possible. Additionally,one or more slide clamps 130 may be included to pinch off flow at adesired point, when equipped. Further, in an embodiment, one or moreinjection port caps 132 may be added to dual lumen IV admin set 100 tocover and clean the at least one macro injection port 116 and the atleast one micro injection port 118. In an embodiment, injection portcaps 132 may be tethered via a tether 134 to respective injection ports(116, 118), to assist in reducing bacteria introduction. Injection portcaps 132 may include antibacterial and/or antiviral agents to cleanrespective injection ports (116, 118) before use and cover the same whennot in use.

As seen in FIG. 2 , in an alternative embodiment, a dual lumen IV adminset 200 may incorporate an alternative roller clamp 202 instead of duallumen clamping device 120. Roller clamp 202 may clamp second lumen 114via roller 204 to regulate flow therethrough, while allowing first lumen112 to pass unobstructed. That is, in the embodiment of dual lumen IVadmin set 200, roller clamp 202 does not have the means to clamp firstlumen 112, and may include a bypass area 206 (shown in more detail inFIGS. 4A-4C) in which first lumen 112 may pass, while maintaining theability to regulate the flow in second lumen 114 with a roller 204.

In addition, dual lumen IV admin set 200 may include a palpable flushpump 208. In an embodiment as shown, flush pump 208 may be ahand-squeezable flowthrough flush pump with a ball valve on one end,though it is contemplated that both ends of flush pump 208 may include aball valve, in some instances. Generally, flush pump 208 may beincorporated into dual lumen IV admin set 200 by connecting a first end,which has a ball valve disposed therein, to be inline with first lumen112 after flow splitter 110 and roller clamp 202.

Moreover, in an embodiment, a pressure valve 210 may be included infirst lumen 112 beneath flush pump 208 to assist in regulating thepressure of the injected fluid from first lumen 112 prior to enteringexit lumen 126 to pass into a patient.

In an embodiment, as mentioned above, flush pump 208 may be ahand-actuated pump (see FIG. 3 ). Flush valve 208 may include a ballvalve 300 at an upper end thereof to prevent backflow. Further, secondlumen 114 may be adhered or otherwise affixed to an outer edge of ballvalve 300 to avoid a loop that could potentially catch on structuralfeatures of patient beds, cabinets, worker clothing, etc. and could pullon the IV set 100. A size of flush valve 208 may vary depending on need.However, a 5 cc ball flush pump is contemplated. As indicated above,while flush pump 208 may be hand-actuated, it is also contemplated thata mechanized pump may be incorporated to assist in flushing themedication through first lumen 112.

Further, in an alternative embodiment, a ball valve may be included ateach end of a flush pump (not shown), and the balls of the ball valvesmay be of a ferrite material. While squeezing, the ball of the top valveforces fluid foreword by overcoming the bottom valve and forcing the topvalve up, thus closing off backflow. In contrast, while letting go ofthe ball at the top, a ball at the bottom of the pump may be sucked upclosing the bottom valve off while filling. In an embodiment, a smallmagnet may be added above the bottom ball. The magnet may keep the lowerball bearing in the closed position preventing flow. Then, squeezing thepump may overcome the force of the magnet and forces enough fluidforward flushing the first lumen.

In FIG. 4A, a side view of roller clamp 202 is shown. Roller 204 isshown at a side of roller clamp 202 opposite bypass area 206. In FIG.4B, a top view of roller clamp 202 is shown, clearly depicting bypassarea 206 in which first lumen 112 passes freely without clamping meansto obstruct flow therethrough. Finally, in FIG. 4C, a bottom view ofroller clamp 202 is shown, depicting roller 204 trapped within a trackalong side walls of roller clamp 202 and against second lumen 114.

FIGS. 5A and 5B depict the opposite components of flow splitter 110 inFIG. 5A and flow merger 124 in FIG. 5B. As explained above, flowsplitter 110 divides the single input flow from single input flow line106 into first lumen 112 and second lumen 114 via a block body structureconfigured to route the flow into the two exiting lumens (112, 114).While at the end of IV set 100, flow merger 124 reunites the separateflows of first lumen 112 and second lumen 114 into a single flow againat exit lumen 126.

The interior invisible structure of a macro injection port 116 isdepicted in greater detail in FIG. 6A via the hashed lines within. Thatis, macro injection port 116 permits flow to continue uninterrupted infirst lumen 112, while providing an injection port IP access into secondlumen 114. Likewise, hashed lines within micro injection port 118,depicted in FIG. 6B, show the interior invisible structure. That is,micro injection port 118 permits flow to continue uninterrupted insecond lumen 114, while providing an injection port IP access into firstlumen 112.

FIG. 7A depicts an embodiment an injection port cap 700 used to cleanthe injection ports IP. Injection port cap 700 may include a rubberizedor silicone-based, hollow, manipulable/movable cover, e.g., a resilient,but malleable nipple 702A. Nipple 702A may have a slit 704, via whichthe injection port IP may be exposed when nipple 702A is pulled to theside so that the injection port IP extends through slit 704, wherebyinjection access is available.

FIG. 7B illustrates an alternative embodiment of injection port cap 700implementing a tethered cap 702B, which may be similar or the same asthose depicted in FIG. 1 (injection port caps 132 as tethered via tether134). Injection port cap 132 may be threaded on an inside thereof toclasp injection port IP securely. However, injection port cap 132 mayalternatively be unthreaded, and merely fit around to be twisted andcleanse injection port IP. Tether 134 may be of flexible and durablematerial attached at a first end to the injection port IP and at asecond, opposing end to cap 132, via which the injection port IP may becovered and/or cleaned.

As indicated above, the embodiments of caps may be attached in otherways, and may include a cleansing solution such as an antibacterial orantiviral solution, which may be in a liquid form and stored in anabsorbent applicator within the cover or cap.

Illustrative Example of a Method of Using a Dual Lumen IV AdministrationSet

Inasmuch as a dual lumen IV admin set has not been implemented prior tothis disclosure, steps for use are described herein. For example, amethod 800 of administering an IV fluid and/or medication to a patientvia a dual lumen IV administration set, as described herein above, mayinclude connecting the dual lumen IV administration set to a patient 802and establishing an IV fluid flow via a first lumen 804. Uponestablishing the IV fluid flow, the administrator may input amedication, drug, or other solution (hereinafter referred to as “drug”)needed into a second lumen 806 that runs parallel to the first lumen,and which second lumen has a flow that rejoins the flow of the firstlumen prior to entering the patient. In connection with inputting thedrug into the second lumen, the administrator may actuate a pump to drawIV fluid from the same source of IV fluid that is providing IV fluid tothe first lumen 808, to flush the drug through the second lumen in arapid manner and cause the drug to be administered at a point in thedual lumen IV administration set that is near an end thereof and priorto entering the patient.

Conclusion

Although several embodiments have been described in language specific tostructural features and/or methodological acts, it is to be understoodthat the claims are not necessarily limited to the specific features oracts described. Rather, the specific features and acts are disclosed asillustrative forms of implementing the claimed subject matter.

1.-20. (canceled)
 21. A method of administering an IV to a patient, themethod comprising steps of: connecting a dual lumen IV set to thepatient, the dual lumen IV set including a first lumen having an innerdiameter of a first value, and a second lumen having an inner diameterof a second value that is greater than the first value; establishing anIV flow through the first lumen; inputting a drug into the second lumenof the dual lumen IV set; actuating a flush pump to draw IV fluid intothe first lumen to regulate a volume of the IV flow; and merging, into amerged flow, the IV flow in the first lumen and the drug in the secondlumen, the merged flow being merged prior to entering the patient. 22.The method according to claim 21, further comprising splitting the IVflow via a flow splitter to split input from a single flow input lineinto: a first flow into the first lumen, and a second flow into thesecond lumen.
 23. The method according to claim 22, wherein the step ofmerging includes merging a flow output via a flow merger to combine thefirst flow that is output from a distal end of the first lumen and thesecond flow that is output from a distal end of the second lumen to formthe merged flow in an exit lumen.
 24. The method according to claim 23,further comprising providing an injection port that intersects the firstlumen after the flush pump and prior to the flow merger.
 25. The methodaccording to claim 23, further comprising providing an injection portthat intersects the second lumen after the flush pump and prior to theflow merger.
 26. The method according to claim 23, further comprisingproviding: a first injection port that intersects the first lumen afterthe flush pump and prior to the flow merger, and a second injection portthat intersects the second lumen after the flush pump and prior to theflow merger.
 27. The method according to claim 23, further comprisingproviding: a first injection port that intersects the first lumen afterthe flush pump and prior to the flow merger, a second injection portthat intersects the second lumen after the flush pump and prior to theflow merger, and a third injection port that intersects the second lumenabove the flush pump on the first lumen and before a lumen clamp on thesecond lumen.
 28. The method according to claim 22, wherein the flushpump is disposed inline with the first lumen after the flow splitter,the flush pump configured to regulate the volume of the IV flow viaactuation of a valve disposed at a flow input end of the flush pump. 29.The method according to claim 21, further comprising providing the firstlumen as coupled longitudinally at least in part to the second lumenbetween respective outer surfaces thereof
 30. The method according toclaim 21, wherein the step of actuating the flush pump includes manuallysqueezing the flush pump via hand.
 31. A method of administering an IVto a patient, the method comprising steps of: connecting a dual lumen IVset to the patient, the dual lumen IV set including a first lumen havingan inner diameter of a first value, and a second lumen having an innerdiameter of a second value that is greater than the first value;establishing a first IV flow through the first lumen; establishing asecond IV flow through the second lumen; providing an injection port inthe second lumen for when a patient needs a drug injected; actuating aflush pump to draw IV fluid into the first lumen to regulate a volume ofthe first IV flow; and merging, into a merged flow, the first IV flow inthe first lumen and the second IV flow in the second lumen, the mergedflow being merged prior to entering the patient.
 32. The methodaccording to claim 31, wherein the step of merging includes merging aflow output via a flow merger to combine the first IV flow that isoutput from a distal end of the first lumen and the second IV flow thatis output from a distal end of the second lumen to form the merged flowin an exit lumen.
 33. The method according to claim 31, wherein theinjection port is a first injection port, and wherein the method furthercomprises providing a second injection port that intersects the firstlumen after the flush pump and prior to the flow merger.
 34. The methodaccording to claim 31, wherein the injection port is a first injectionport that intersects the second lumen before the flush pump, and whereinthe method further comprises providing a second injection port thatintersects the second lumen after the flush pump and prior to the flowmerger.
 35. The method according to claim 31, wherein the injection portis a first injection port that intersects the second lumen before theflush pump, and wherein the method further comprises: a second injectionport that intersects the first lumen after the flush pump and prior tothe flow merger, and a third injection port that intersects the secondlumen after the flush pump and prior to the flow merger.
 36. The methodaccording to claim 31, wherein the flush pump is disposed inline withthe first lumen after a flow splitter, the flush pump configured toregulate the volume of the first IV flow via actuation of a valvedisposed at a flow input end of the flush pump.
 37. The method accordingto claim 31, further comprising providing the first lumen as coupledlongitudinally at least in part to the second lumen between respectiveouter surfaces thereof.
 38. The method according to claim 31, whereinthe step of actuating the flush pump includes manually squeezing theflush pump via hand.